LABELS · 94c147fd-c8bd-428c-911b-f1aba4ab8729

CINVANTI

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-04-01
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen. nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen. ( 1 ) delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen. ( 1 ) nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. ( 1 ) Limitations of Use : CINVANTI has not been studied for treatment of established nausea and vomiting. ( 1 ) Limitations of Use CINVANTI has not been studied for the treatment of established nausea and vomiting.

Full extracted label fields

application numbers

NDA209296

boxed warning exact

brand names

CINVANTI

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4c218d3a-a508-4abc-9ed8-a6e8e191d1b4

generic names

APREPITANT

94c147fd-c8bd-428c-911b-f1aba4ab8729

indications and usage exact

1 INDICATIONS AND USAGE CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen. nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen. ( 1 ) delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen. ( 1 ) nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. ( 1 ) Limitations of Use : CINVANTI has not been studied for treatment of established nausea and vomiting. ( 1 ) Limitations of Use CINVANTI has not been studied for the treatment of established nausea and vomiting.

indications and usage tables exact

is original packager

true

manufacturer names

Heron Therapeutics, Inc.

matched search terms

cancer

package ndcs

47426-201-01

product ndcs

47426-201

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

1995150
1995155

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

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total: 830

terms

https://open.fda.gov/terms/

sha256

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url

source url

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spl effective date

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spl effective time

20260401

spl set id

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spl version

substance names

APREPITANT

uniis

1NF15YR6UY

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA209296
payload
all indexed label documents
Appl No
209296
Application Docs Date
2017-11-13 00:00:00
Application Docs ID
50385
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209296s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
209296
Application Docs Date
2019-02-27 00:00:00
Application Docs ID
57823
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209296s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
209296
Application Docs Date
2019-10-22 00:00:00
Application Docs ID
60632
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209296s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
209296
Application Docs Date
2022-04-20 00:00:00
Application Docs ID
70796
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209296Orig1s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
209296
Application Docs Date
2024-03-05 00:00:00
Application Docs ID
77721
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209296Orig1s015lbl.pdf
Submission No
15
Submission Type
SUPPL
all submission records
Appl No
209296
Review Priority
STANDARD
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2017-11-09 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
209296
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
3
Submission Status
AP
Submission Status Date
2019-02-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
209296
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
4
Submission Status
AP
Submission Status Date
2019-10-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
209296
Review Priority
N/A
Submission Class Code ID
4
Submission No
8
Submission Status
AP
Submission Status Date
2022-03-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
209296
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
15
Submission Status
AP
Submission Status Date
2024-03-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA209296
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209296
has approved submission record
true
latest approved submission date
2024-03-05
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
209296
Application Docs Date
2024-03-05 00:00:00
Application Docs ID
77721
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209296Orig1s015lbl.pdf
Submission No
15
Submission Type
SUPPL
official application record
Appl No
209296
Appl Public Notes
Appl Type
NDA
Sponsor Name
HERON THERAPS INC
openfda application present
true
products
Active Ingredient
APREPITANT
Appl No
209296
Drug Name
CINVANTI
Form
EMULSION;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
130MG/18ML (7.2MG/ML)
marketing status
Prescription

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

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use intent

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Passage 2 · positive indication candidate

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exact text: with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen. nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen. ( 1 ) delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen. ( 1 ) nausea and vomiting associated with ini
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Passage 3 · unclassified context

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regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 6 · limitation of use

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exact text: ) nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. ( 1 ) Limitations of Use : CINVANTI has not been studied for treatment of established nausea and vomiting. ( 1 ) Limitations of Use CINVANTI has not been studied for the treatment of established nausea and vomiting.
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approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice